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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 228 drug applications between 9 March 2023 and 15 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 37 drug names.

2023/03/09 – 2023/03/15

Period
2023/03/09 to 2023/03/15, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
228
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
10

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

228filings, 50 of them generic

By application type

Application typeFilings
Supplement105
Generic50
New drug43
Import19
Import re-registration6
Unspecified5

By drug type

Drug typeFilings
Chemical drug156
Therapeutic biologic37
TCM29
Biologic5
Prophylactic biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution2234
2氧 · No verified English name2215
3Famotidine Injection228
4Glucosamine Sulfate Capsules2251
5Obeticholic Acid Tablets210
6Dimethyl Fumarate Delayed-release Capsules210
7Empagliflozin And Linagliptin Tablets210
8Amlodipine Besylate and Atorvastatin Calcium Tablets212
9氯雷他定糖浆 · No verified English name217
10Caspofungin Acetate for Injection218

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

145 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tianjin He Zhi Pharma Group Co., Ltd. romanized990
2Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
3Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized550
4MSD Pharma (Singapore) Pte. Ltd420
5Qilu Pharmaceutical (Hainan) Co., Ltd424
6Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized410
7Guangxi Ji Min Tang Pharma Co., Ltd. romanized330
8Guangxi Yu Yuan Pharma Co., Ltd. romanized330
9Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized330
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized320

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

80 this week

AcceptedDrugApplicants
2023/03/15Import · Class 1 Tarlatamab · No verified English nameJXSL2300054 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/15Import · Class 1 Tarlatamab · No verified English nameJXSL2300053 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/15Import · Class 1 Tarlatamab · No verified English nameJXSL2300052 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/15Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2300792 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/03/15Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2300791 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/03/15New drug · Class 1 FP002注射液 · No verified English nameCXSL2300192 Guangdong Fei Peng Pharmaceutical Co., Ltd. romanized
2023/03/15New drug · Class 1 MWN101注射液 · No verified English nameCXSL2300191 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2023/03/15New drug · Class 1 MWN101注射液 · No verified English nameCXSL2300190 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2023/03/15New drug · Class 3.3 BR201注射液 · No verified English nameCXSL2300189 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2023/03/15New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2300188 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/03/15New drug · Class 1 Domvanalimab注射液 · No verified English nameCXSL2300187 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/03/15New drug · Class 1 TNM006注射液 · No verified English nameCXSL2300186 Shenzhen Shi Zhi Xin Bio Technology Co., Ltd. romanized
2023/03/15New drug · Class 1 PB-718注射液 · No verified English nameCXHL2300314 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/03/15New drug · Class 1 HS336片 · No verified English nameCXHL2300313 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2023/03/15New drug · Class 1 HS336片 · No verified English nameCXHL2300312 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2023/03/14Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2300027 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2023/03/14Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2300026 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2023/03/14Import · Class 1 DS-1062a · No verified English nameJXSL2300051 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2023/03/14Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2300047 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2023/03/14Generic · Class 3 Peramivir InjectionCYHS2300785 Xian Jing Xi Shuang He Pharma Co., Ltd. romanized
2023/03/14Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2300779 Hunan Chun Jian Pharmaceuticals Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/03/14Generic · Class 3 Cefazolin Sodium for InjectionCYHS2300778 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized
2023/03/14Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2300777 Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized
2023/03/14Generic · Class 3 Nicorandil for InjectionCYHS2300776 Sichuan Bai Li Pharma Co., Ltd. romanized
2023/03/14New drug · Class 2.4 CMAB009注射液 · No verified English nameCXSS2300012 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2023/03/14New drug · Class 1 TQC2731注射液 · No verified English nameCXSL2300185 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/03/14New drug · Class 1 VUM02注射液 · No verified English nameCXSL2300184 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2023/03/14New drug · Class 1 VUM02注射液 · No verified English nameCXSL2300183 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2023/03/14New drug · Class 2.1; 2.2; 2.4 YMP透皮贴剂 · No verified English nameCXHL2300311 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2023/03/14New drug · Class 2.1; 2.2; 2.4 YMP透皮贴剂 · No verified English nameCXHL2300310 Beijing Tai De Pharmaceutical Co., Ltd. romanized

50 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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